Comparative Analysis of Intraoperative Effect Dexmedetomidine and Fentanyl as an Adjuvant to Heavy Bupivacaine in Spinal Anaesthesia in Lower Limb Orthopedic Surgeries to Evaluate the Hemodynamic Stability and Onset and Duration of Motor Block of Using Intrathecal Dexmedetomidine and Fentanyl

NCT07078201 | Recruiting Phase 4

• 1 other identifier: IRB00012098- Serial0307331
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Spinal anesthesia is the most widely employed procedure for lower limb orthopedic operations, as it is very cost-effective and simple to apply. These advantages could be restricted because presently existing local anesthetic drugs had relatively short length of action. (1) Spinal anesthesia with 0.5% heavy bupivacaine (hyperbaric) is a common technique, still there was burden of its short duration of action. To overcome this issue, there was a continuous search for an ideal adjuvant.(2) Adjuvants were mostly added to local anesthetic drugs to increase their effectiveness, speedy onset, increase the period of the block, and reduce the local anesthetics dosage, thus reduction their adverse effects.(3) Such adjuvants had been beneficial in extension of analgesia along with initiation of movement though their related side effects.(4)

Conditions

Spinal Anesthesia Duration

Outcome Measures

Primary Outcomes (4)

• to evaluate duration of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

  Duration of motor block had been evaluated by the time taken to return from complete Bromage motor block (bromage 3) to scale 0. Motor block was evaluated with Modified Bromage scale (6) Bromage 0: The patient could move the hip, knee, and ankle. Bromage 1: The patient could move the hip but had ability to move the knee and ankle. Bromage 2: The patient could move the hip and knee but had ability to move the ankle. Bromage 3: The patient could not move the hip, knee, and ankle.

  7 hour

• evaluate onset of motor block of using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

  onset time of bromage 3 motor block had been recorded (Onset of the motor block; period between the ending of intrathecal drug injection and entire motor paralysis)

  10 minutes

• to evaluate non invasive mean blood pressure using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

  Intraoperatively non-invasive mean blood pressure had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.

  90 minutes

• to evaluate the heart rate using intrathecal dexmedetomidine and fentanyl as an adjuvant to heavy bupivacaine in lower limb orthopedic surgeries.

  Intraoperatively heart rate had been documented, every 15 min for first 30minutes then every 30 min till the end of the surgery.

  90 minutes

Secondary Outcomes (1)

• Complications would be noted Intraoperative

  90 minutes

Study Arms (2)

Group D

ACTIVE COMPARATOR

Drug: Dexmedetomidine

Group F

ACTIVE COMPARATOR

Drug: fentanyl

Interventions

Dexmedetomidine DRUG

patients received 3 mL volume of 0.5% hyperbaric bupivacaine and 4 µg dexmedetomidine in 0.5 mL of normal saline intrathecal (dexmedetomidine 100 µg/mL diluted in 12.5 ml preservative-free normal saline, 0.5 ml had been withdrawn).

Group D

fentanyl DRUG

patients received 3 mL volume of 0.5% hyperbaric bupivacaine with 25 µg fentanyl (0.5 mL) intrathecal.

Group F

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient aged range from 20 to 60 years
• ASA 1 and 2
• Patient prepared for elective lower limb orthopaedic surgeries.
• Height 150-180 cm.
• Weight 50-70 kg. 6- Either sex male or female.

You may not qualify if:

• \- 1- Patient refusal. 2- Patient had absolute contraindication to spinal anaesthesia. 3-Patients with neurological disorders, pregnancy, local infection at the site of injection.
• Patients suffering from dysrhythmia or heart block. 5- Patients with ASA 3 or more.

Sponsors & Collaborators

• Nashwa Ahmed: lead

Study Sites (1)

Port said university

Port Said, 42111, Egypt

RECRUITING

Related Publications (8)

• Gupta R, Verma R, Bogra J, Kohli M, Raman R, Kushwaha JK. A Comparative study of intrathecal dexmedetomidine and fentanyl as adjuvants to Bupivacaine. J Anaesthesiol Clin Pharmacol. 2011 Jul;27(3):339-43. doi: 10.4103/0970-9185.83678.

  PMID: 21897504 RESULT

• Rajasekaran S, Murugaih S, Anandan A, Ramalingam A. A comparative study of intrathecal clonidine VS dexmedetomidine in caesarean patients. Indian Journal of Clinical Anaesthesia 2018;5(1):68-74.

  RESULT

• Sharma E, Gupta B, Verma RK, Devra V. Block characteristics of different doses of intrathecal dexmedetomidine when combined with low dose heavy bupivacaine for gynecological surgeries: a double blind, randomised comparative study. Sch. J. App. Med. Sci., 2017; 5(6D):2286-2294.

  RESULT

• Ahmed SA, Lotfy HA, Mostafa TAH. The effect of adding dexmedetomidine or dexamethasone to bupivacaine-fentanyl mixture in spinal anesthesia for cesarean section. J Anaesthesiol Clin Pharmacol. 2024 Jan-Mar;40(1):82-89. doi: 10.4103/joacp.joacp_396_22. Epub 2024 Mar 14.

  PMID: 38666154 RESULT

• Gupta A, Gupta KL, Yadav M. To evaluate the effect of addition of dexmedetomidine to hyperbaric bupivacaine intrathecally in infraumblical surgeries. International Journal of Contemporary Medical Research 2016;3(7):2136-2138.

  RESULT

• Kumar S, Choudhury B, Varikasuvu SR, Singh H, Kumar S, Lahon J, Saikia D. A Systematic Review and Meta-analysis of Efficacy and Safety of Dexmedetomidine Combined With Intrathecal Bupivacaine Compared to Placebo. Cureus. 2022 Dec 12;14(12):e32425. doi: 10.7759/cureus.32425. eCollection 2022 Dec.

  PMID: 36644042 RESULT

• Reddy NG, Sekar RG, Ahmed CJ, Himabindu M, Mallika CH, Tejaswini PK. Intrathecal nalbuphine versus dexmedetomidine as an adjuvant in spinal anaesthesia for lower limb and lower abdominal surgeries. Journal of Cardiovascular Disease Research 2023;14(2): 825-883.

  RESULT

• Zhang Y, Shan Z, Kuang L, Xu Y, Xiu H, Wen J, Xu K. The effect of different doses of intrathecal dexmedetomidine on spinal anesthesia: a meta-analysis. Int J Clin Exp Med 2016;9(10):18860-18867.

  RESULT

MeSH Terms

Interventions

Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Central Study Contacts

Nashwa gomaa Ahmed, MD

CONTACT

00201005289328; dr_nashwa_2008@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: , Lecturer of Anaesthesia and Surgical Intensive Care, Faculty of Medicine, Port Said University, Egypt

Study Record Dates

• First Submitted: June 28, 2025
• First Posted: July 22, 2025
• Study Start: July 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: December 25, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)